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Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants (PRESENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01387542
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Paliperidone extended release (ER)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Period Title: Overall Study
Started 40
Treated 38
Completed 32
Not Completed 8
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             1
Changed diagnosis             1
Insufficient response             1
Non-compliant             1
Lost to Follow-up             1
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
41.13  (12.314)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
23
  60.5%
Male
15
  39.5%
1.Primary Outcome
Title Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
Hide Description The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening .
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 3.55  (1.155)
Change at Week 10 0.82  (1.036)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Friedman test
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
Hide Description The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 58.95  (15.710)
Change at Week 2 -4.289  (9.647)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
Hide Description The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-7.053  (11.463)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
Hide Description The PSP scale assesses degree of a participant’s dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame Baseline, Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description:
Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-9.868  (14.640)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone Extended Release (ER)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method Paired t-test
Comments [Not Specified]
Time Frame 10 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Extended Release (ER)
Hide Arm/Group Description Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
All-Cause Mortality
Paliperidone Extended Release (ER)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Extended Release (ER)
Affected / at Risk (%) # Events
Total   1/40 (2.50%)    
Psychiatric disorders   
Mania * 1  1/40 (2.50%)  1
Elevated mood * 1  1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone Extended Release (ER)
Affected / at Risk (%) # Events
Total   22/40 (55.00%)    
Cardiac disorders   
Palpitation * 1  2/40 (5.00%) 
Ear and labyrinth disorders   
Vertigo * 1  2/40 (5.00%) 
Gastrointestinal disorders   
Nausea * 1  3/40 (7.50%) 
Constipation * 1  2/40 (5.00%) 
Diarrhea * 1  2/40 (5.00%) 
Nervous system disorders   
Drowsiness * 1  6/40 (15.00%) 
Headache * 1  6/40 (15.00%) 
Extrapyramidal disorder * 1  3/40 (7.50%) 
Psychiatric disorders   
Insomnia * 1  5/40 (12.50%) 
Skin and subcutaneous tissue disorders   
Pruritis * 1  2/40 (5.00%) 
Vascular disorders   
Hypotension * 1  2/40 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 14.0
Study had an open-label trial design with lack of a comparator arm; therefore it was difficult to conclude the efficacy and safety results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on the PI is that the sponsor can review results communications prior to publication and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The paper that incorporates confidential information requires Sponsor’s written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application.
Results Point of Contact
Name/Title: Medical Affairs Director
Organization: Janssen-Cilag Ltd.: 106 Moo 4 Lad Krabang Industrial Estate, Chalongkrung Rd., Lamplatew, Lad Krabang, Bangkok 10520
Phone: +66 2 7397200 ext 5888
Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01387542     History of Changes
Other Study ID Numbers: CR015976
R076477SCH4037 ( Other Identifier: Janssen-Cilag Ltd.,Thailand )
First Submitted: June 30, 2011
First Posted: July 4, 2011
Results First Submitted: January 29, 2013
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013